FDA to hold hearing on creation of behind-the-counter drug classification

By Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration in Thursday’s Federal Register announced a public meeting to obtain comments regarding the creation of a third-class of drugs, or behind-the-counter drugs.

The FDA is currently fielding public comment as it explores the public health benefit of certain drugs being “available without a prescription but only after intervention by a pharmacist.”

The public meeting will be held Nov. 14 from 8 a.m. to 5 p.m. at the National Transportation Safety Board Conference Center in Washington.

Historically, the Consumer Healthcare Products Association, which represents manufacturers of nonprescription medicines, has stood against any third class of drugs. The American Pharmacists Association has in the past proposed a “pharmacy-only” classification of drugs and the National Association of Chain Drug Stores has in the past declined to take a position one way or the other without a clearer understanding of any proposed BTC system impacts on the industry, including reimbursement issues and time commitments on behalf of the pharmacist.

FDA commissioner Andrew von Eschenbach first brokered the third-class-of-drugs topic earlier this year at the CHPA annual meeting.